Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients

August 5, 2019 updated by: Jonathan Purnell, Oregon Health and Science University

Hypothalamic fMRI Response to Nutrients

The purpose of this study is to identify how certain parts of the brain that control appetite respond to changes in dietary carbohydrate and fat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To measure fMRI signal change in hypothalamic and brainstem centers associated with control of food intake and energy expenditure in response to IV glucose, fructose, and saline. The fMRI response to these nutrients will then be compared in obese vs. lean subjects. Frequently timed blood samples will be obtained for measurement of nutrients (i.e., glucose) and blood levels of other factors (i.e., insulin, ghrelin, lactate) during these infusion protocols, and to test associations between these levels and the fMRI response.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 year to 45 years of age
  • BMI 18 to 25 kg/m2 (25 subjects) and 30 to 40 kg/m2 (25 subjects), matched for age and sex.
  • At maximal lifetime weight.
  • Weight stable for at least 3 months.

Exclusion Criteria:

  • Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
  • Subjects taking psychiatric or centrally-acting (CNS) medications, or who are diagnosed with a psychiatric or neurological illness, including: depression, anorexia, bulimia, and seizure disorder.
  • Subjects who have lost weight as a result of dieting, pharmacological treatment, or bariatric surgery.
  • Weight > 350 lbs or girth > 60 inches (the limits of the MR machine)
  • Exercise > 30 minutes, 3 times a week.
  • Alcohol consumption > 2 drinks / day.
  • Weight > 300 lbs (150 kg) (weight limit for MR machine).
  • Blood glucose > 100 mg/dL, abnormal creatinine or liver function tests.
  • Illicit drug use.
  • Pregnancy.
  • Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate, protein, or fat intakes.
  • Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips.
  • Those with claustrophobia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Dietary supplement: saline
IV saline
Experimental: Glucose
IV glucose
Dietary supplement: glucose
0.3mg/kg of glucose
Active Comparator: Fructose
Dietary supplement: fructose
fructose IV bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcomes of this aim will be the change in fMRI response in the hypothalamus to IV glucose, to IV glucose during intralipid infusion, and to the IV glucose alone, in the lean and obese groups separately.
Time Frame: 0,1,2 and 3 months
0,1,2 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2006

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 30, 2008

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eIRB #938
  • 791 (Oregon Clinical and Translational Research Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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